Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:42 PM
Ignite Modification Date: 2025-12-25 @ 1:51 PM
NCT ID: NCT01241292
Description: None
Frequency Threshold: 5
Time Frame: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Study: NCT01241292
Study Brief: Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BMS 10mg/kg + Ld None 0 None 2 3 3 3 View
BMS 20mg/kg + Ld None 0 None 3 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Gingival erosion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Oral fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Creatinine renal clearance decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Electrocardiogram qt prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Glucose tolerance impaired SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Haemorrhage subcutaneous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Haemorrhage subepidermal SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Penile ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View